BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 15814841 · Received November 17, 2022

    Report

    Report Number
    2916596-2022-15075
    Event Type
    Death
    Date Received
    November 17, 2022
    Date of Event
    November 1, 2014
    Report Date
    November 17, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS LITERATURE REVIEW WAS ORIGINALLY CAPTURED UNDER MFR# 2916596-2022-14421. SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBERS ARE DOCUMENTED AS UNKNOWN. THE EVENT DATE HAS BEEN ESTIMATED AS THE DATA WAS COLLECTED BETWEEN NOVEMBER 2014 AND NOVEMBER 2021. ARTICLE TITLE: LESS IS BETTER? COMPARING EFFECTS OF MEDIAN STERNOTOMY AND THORACOTOMY SURGICAL APPROACHES FOR LEFT VENTRICULAR ASSIST DEVICE IMPLANTATION ON POSTOPERATIVE OUTCOMES AND VALVULOPATHY. JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY ELSEVIER INC. (2022). VINOGRADSKY, ALICE, DIVISION OF CARDIAC, THORACIC & VASCULAR SURGERY, DEPARTMENT OF SURGERY, COLUMBIA UNIVERSITY IRVING MEDICAL CENTER, NEW YORK, NY. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE. MANUFACTURER'S INVESTIGATION CONCLUSION: A SPECIFIC CAUSE FOR THE REPORTED PATIENT OUTCOMES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION, AND A DIRECT CORRELATION WITH HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) COULD NOT BE CONCLUSIVELY ESTABLISHED. THE STUDY COMPARED OUTCOMES AFTER LEFT VENTRICULAR ASSIST DEVICE (LVAD) IMPLANTATION PERFORMED VIA MEDIAN STERNOTOMY OR LATERAL THORACOTOMY. A TOTAL OF 222 ADULT PATIENTS IMPLANTED WITH A HEARTMATE 3 LVAD BETWEEN NOVEMBER OF 2014 AND NOVEMBER OF 2021 WERE ANALYZED. A TOTAL OF 6 PATIENTS EXPIRED IN-HOSPITAL FOLLOWING DEVICE IMPLANT. ONE-YEAR SURVIVAL FOR THE LATERAL AND MEDIAN STERNOTOMY GROUPS WAS 95.56% AND 90.61%, RESPECTIVELY. SPECIFIC DEVICE SERIAL NUMBERS WERE NOT PROVIDED, AND NO PRODUCT WAS AVAILABLE FOR EVALUATION. THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS) INSTRUCTIONS FOR USE (IFU), IS CURRENTLY AVAILABLE. SECTION 1 ¿INTRODUCTION¿ OF THIS DOCUMENT LISTS EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, INCLUDING DEATH. THE APPLICABLE SERIAL/LOT NUMBERS OF THE HEARTMATE 3 LVAD'S (LEFT VENTRICULAR ASSIST DEVICES) ASSOCIATED WITH THE REPORTED EVENTS WERE NOT PROVIDED AND WERE UNABLE TO BE IDENTIFIED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿MICROEMBOLIC SIGNAL MONITORING IN PATIENTS WITH LEFT VENTRICULAR ASSIST DEVICES HEARTMATE 3 AND HEARTWARE¿ASSOCIATION WITH ANTITHROMBOTIC TREATMENT AND CEREBROVASCULAR EVENTS¿ THAT A SECONDARY OUTCOME OF THE STUDY WAS IN-HOSPITAL MORBIDITY AND MORTALITY. A TOTAL OF 6 PATIENTS WERE REPORTED TO HAVE EXPIRED DURING THE STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200321 HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death